Senior Quality Validation Engineer

Fixed-term contract of 9 months with a possibility to remain in the company afterwards

How will you make an impact?

The Quality Validation Engineer is responsible for reviewing, consulting, and preparing documentation related to the validation of analytical methods and production, cleaning, and shipment processes to ensure compliance with ISO9001, ISO13485, GMP, and 21 CFR part 820 requirements.

What will you do?

• Take ownership of appropriate and timely preparation of documentation
• Ensure accurate and timely data entry into the accounting system
• Propose changes, prepare, coordinate and approve QMS / EMS documents in the internal data system
• Advise and ensure compliance of production, cleaning, shipment and method validation processes in accordance with ISO13485 and GMP requirements (review of validation plans / protocols, experimental results, validation processes and reports)
• Ensure timely monitoring of parameters of validated processes and statistical analysis of data by providing information for product quality review
• Participate in the company's external / internal audits, quality assurance processes and training
• Advise the line manager about all non-standard situations related to line functions

EDUCATION

• University degree in Biology / Chemistry / Biochemistry / Bioengineering (Bachelor)

KNOWLEDGE, SKILLS, ABILITIES

• At least 2 years of work experience by specialty (advantage - work experience within a regulated environment)
• Excellent knowledge of English
• Knowledge and skills of ISO 13485, GMP standards and quality management systems, analytical methods, process validation, equipment / systems qualification
• Knowledge of the aseptic manufacturing principles and rules
• Knowledge of work and behavior in a controlled environment
• Excellent computer literacy skills (MS Office)
• Organization, strong communication and planning skills

• Meaningful, mission-based work
• The innovative environment of the rapidly growing international company
• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential
• A great opportunity to be part of a dynamic global organization and work with experienced professionals
• Work in an ambitious team
• Possibility to work from home
• No shift work
• Monthly salary of 1,800 - 2,600 Eur before taxes